Gentris Corporation Expands GentriSure Line of Human Genomic DNA Reference Controls
Controls for CYP2C9, VKORC1 and CYP2C19 genes eliminate informed consent and consistency issues for labs using leftover specimens or synthetic materials.
Raleigh, NC, November 16, 2006 --(PR.com)-- Gentris Corporation (Gentris), a leading global provider of applied clinical pharmacogenomic services and diagnostic product solutions, today announced the expansion of the GentriSure line of Human Genomic DNA Reference Controls to include relevant polymorphisms for the Cytochrome P450 2C9 (CYP2C9), Vitamin K Epoxide Reductase Complex Subunit 1 (VKORC1) and Cytochrome P450 2C19 (CYP2C19) genes.
This announcement comes shortly after an FDA advisory committee recommended the re-labeling of the drug Coumadin® (generic warfarin) to include a black box warning to indicate that the popular anticoagulant carries a significant risk of serious or fatal bleeding. Patient genotypes for CYP2C9 and VKORC1 are known to explain more than 50 percent of warfarin response. Approximately, one third of the 30 million patients prescribed warfarin in the United States each year carry a mutation of CYP2C9 that is closely associated with the drug’s adverse affects1. Genetic tests are available to identify patients at risk for experiencing adverse reactions to the drug, however, until the introduction of the GentriSure line of Human Genomic DNA Reference Controls, no consistent source of properly consented material had been available.
“Laboratories conducting 2C9, VKORC1 and 2C19 testing have chosen to use leftover specimens or synthetic material as reference controls, which can lead to serious consistency, reliability and informed consent issues,” commented Gentris president and CEO Michael Murphy. “Proper controls are critical to ensuring that testing meets the high standards set forth by CLIA and other regulatory agencies. GentriSure Human Genomic DNA Reference Controls provide the assurance of well-characterized material and the convenience of a continuous supply of ready-to-use material.”
GentriSure Human Genomic DNA Reference Controls are isolated from immortalized B-lymphoblastoids derived from properly consented individual donors. They are manufactured in a tightly-controlled environment and undergo rigorous quality control testing including DNA integrity and functional testing. All defining mutations are verified by bi-directional sequencing. Each vial contains 10 microliters at a concentration of 50 nanograms per microliter. They are available for research use only and not for use in diagnostic procedures.
In April 2006 Gentris introduced Human Genomic DNA Reference Controls for the Cytochrome P450 2D6 (CYP2D6) gene. The company presently offers 22 control configurations for CYP2D6, CYP2C19, CYP2C9 and VKORC1 and is currently developing a commercial diagnostic kit for CYP2C9 and VKORC1 which would enable rapid genetic testing for warfarin dosing. The test is expected to be available in 2007.
1Lesko (FDA), Clinical Pharmacology Subcommittee (CPSC) of the Advisory Committee for Pharmaceutical Sciences, November 2005.
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About Gentris Corporation
Gentris Corporation is a leading global provider of applied clinical pharmacogenomic services and diagnostic product solutions. As pioneers in the field of pharmacogenomics, Gentris helps pharmaceutical companies and clinical research organizations effectively integrate pharmacogenomics into their drug development programs to deliver safer, more effective compounds to the market sooner. Gentris is developing validated reference controls and diagnostic test kits that will bring the promise of personalized medicine to physicians and patients, which will enhance patient management, improve patients' response to therapy and revolutionize medicine through pharmacogenomics. For additional information, please visit http://www.gentris.com.
This announcement comes shortly after an FDA advisory committee recommended the re-labeling of the drug Coumadin® (generic warfarin) to include a black box warning to indicate that the popular anticoagulant carries a significant risk of serious or fatal bleeding. Patient genotypes for CYP2C9 and VKORC1 are known to explain more than 50 percent of warfarin response. Approximately, one third of the 30 million patients prescribed warfarin in the United States each year carry a mutation of CYP2C9 that is closely associated with the drug’s adverse affects1. Genetic tests are available to identify patients at risk for experiencing adverse reactions to the drug, however, until the introduction of the GentriSure line of Human Genomic DNA Reference Controls, no consistent source of properly consented material had been available.
“Laboratories conducting 2C9, VKORC1 and 2C19 testing have chosen to use leftover specimens or synthetic material as reference controls, which can lead to serious consistency, reliability and informed consent issues,” commented Gentris president and CEO Michael Murphy. “Proper controls are critical to ensuring that testing meets the high standards set forth by CLIA and other regulatory agencies. GentriSure Human Genomic DNA Reference Controls provide the assurance of well-characterized material and the convenience of a continuous supply of ready-to-use material.”
GentriSure Human Genomic DNA Reference Controls are isolated from immortalized B-lymphoblastoids derived from properly consented individual donors. They are manufactured in a tightly-controlled environment and undergo rigorous quality control testing including DNA integrity and functional testing. All defining mutations are verified by bi-directional sequencing. Each vial contains 10 microliters at a concentration of 50 nanograms per microliter. They are available for research use only and not for use in diagnostic procedures.
In April 2006 Gentris introduced Human Genomic DNA Reference Controls for the Cytochrome P450 2D6 (CYP2D6) gene. The company presently offers 22 control configurations for CYP2D6, CYP2C19, CYP2C9 and VKORC1 and is currently developing a commercial diagnostic kit for CYP2C9 and VKORC1 which would enable rapid genetic testing for warfarin dosing. The test is expected to be available in 2007.
1Lesko (FDA), Clinical Pharmacology Subcommittee (CPSC) of the Advisory Committee for Pharmaceutical Sciences, November 2005.
###
About Gentris Corporation
Gentris Corporation is a leading global provider of applied clinical pharmacogenomic services and diagnostic product solutions. As pioneers in the field of pharmacogenomics, Gentris helps pharmaceutical companies and clinical research organizations effectively integrate pharmacogenomics into their drug development programs to deliver safer, more effective compounds to the market sooner. Gentris is developing validated reference controls and diagnostic test kits that will bring the promise of personalized medicine to physicians and patients, which will enhance patient management, improve patients' response to therapy and revolutionize medicine through pharmacogenomics. For additional information, please visit http://www.gentris.com.
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Gentris Corporation
Jonathan Jordan
919-557-7890
www.gentris.com
Jonathan Jordan
919-557-7890
www.gentris.com
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